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FDA’s Accelerated Pathways Are the New Normal
The FDA’s Accelerated Approval, Breakthrough Therapy Designation, Fast Track, Orphan Drug status, and Qualified Infectious Disease Product pathways facilitate faster development and approval of NDAs addressing unmet needs. According to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one accelerated pathway, while a third used two or more. PAREXEL and the nonprofit Network for Excellence in Healthcare Innovation share results of a survey of twenty national, regional, public, and private payers, which explain how they view these pathways and products.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
